[go: up one dir, main page]

WO2025159844A1 - Dispositifs et procédés de réparation de valvules cardiaques - Google Patents

Dispositifs et procédés de réparation de valvules cardiaques

Info

Publication number
WO2025159844A1
WO2025159844A1 PCT/US2024/058981 US2024058981W WO2025159844A1 WO 2025159844 A1 WO2025159844 A1 WO 2025159844A1 US 2024058981 W US2024058981 W US 2024058981W WO 2025159844 A1 WO2025159844 A1 WO 2025159844A1
Authority
WO
WIPO (PCT)
Prior art keywords
native
balloon
valve
heart valve
implantable device
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/058981
Other languages
English (en)
Inventor
Samuel Jacob KIPPERMAN
David Nathaniel SWARTZ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Edwards Lifesciences Corp
Original Assignee
Edwards Lifesciences Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Edwards Lifesciences Corp filed Critical Edwards Lifesciences Corp
Publication of WO2025159844A1 publication Critical patent/WO2025159844A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having an inflatable pocket filled with fluid, e.g. liquid or gas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0069—Sealing means

Definitions

  • a defective native heart valve may not fully close when it is supposed to, thereby resulting in some undesirable regurgitation of blood.
  • calcium deposits can collect around the native heart valve, thereby narrowing the opening of the valve (referred to as “stenosis”) and restricting blood-flow through the valve.
  • stenosis narrowing the opening of the valve
  • devices and methods for repairing a malfunctioning native heart valve are desirable.
  • the present disclosure is directed to an implantable and expandable coil device implanted around the native valve leaflets, the native chordae tendineae, or both the Attorney Docket No: THVMC-23550WO01 native valve leaflets and the native chordae tendineae of the native heart valve.
  • the coil device can apply an adjustable inward radial force on a native heart valve, increasing tension within the native valve leaflets and/or the native chordae tendineae to reduce regurgitation.
  • a prosthetic heart valve can be deployed within the coil device, the coil device acting as a docking device for the prosthetic heart valve.
  • An implantable device for treating a native heart valve can comprise a support member comprising a first end, a second end, and a coiled section disposed between the first end and the second end.
  • the implantable device can comprise one or more of the components disclosed herein.
  • the implantable device can comprise a balloon.
  • the balloon can extend radially around at least a portion of the coiled section of the support member.
  • the balloon can define an inner lumen of the implantable device.
  • the balloon can move from a delivery configuration to a deployed configuration.
  • the inner lumen can have a first inner diameter in the delivery configuration and a second inner diameter in the deployed configuration. [0011] In some examples, the second inner diameter can be smaller than the first inner diameter.
  • the balloon can comprise an inflation port through which a fluid can be injected to expand the balloon. [0013] In some examples, the balloon can comprise a first segment and a second segment. [0014] In some examples, the first segment of the balloon can move from the delivery configuration to the deployed configuration defining the second inner diameter. Attorney Docket No: THVMC-23550WO01 [0015] In some examples, the second segment of the balloon can move to a deployed configuration defining third inner diameter.
  • the third inner diameter can be different than the second inner diameter.
  • the device can further comprise an additional balloon extending radially around at least a portion of the coiled section of the support member.
  • the additional balloon can move to a deployed configuration defining a fourth diameter.
  • the balloon can comprise a cover disposed over at least a portion of the balloon.
  • the coiled section of the support member can encircle native leaflets and native chordae tendineae of the native heart valve.
  • the coiled section and the balloon in the deployed configuration together can apply an inward radial force on the native heart valve to increase tension within the native valve leaflets, the native chordae tendineae, or both the native valve leaflets and the native chordae tendineae to reduce regurgitation through the native valve.
  • the inward radial force can be adjusted.
  • the coiled section of the support member can receive a prosthetic heart valve and secure the prosthetic heart valve relative to the native anatomy.
  • the implantable device can comprise a braid extending radially around at least a portion of the coiled section of the support member.
  • the braid can be movable from a delivery configuration to a deployed configuration.
  • Attorney Docket No: THVMC-23550WO01 [0026]
  • the braid can comprise a first end portion and a second end portion, where the first end portion can be fixed to the support member and the second end portion can translate axially along the support member to expand the braid.
  • the second end portion can be fixed to the coiled section of the support member after the braid is expanded.
  • a cover can be disposed over at least a portion of the braid.
  • the braid can comprise a lead screw mechanism or a ratcheting mechanism to translate the second end axially along the support member during expansion.
  • an implantable device for treating a native heart valve comprises a support member comprising a first end, a second end, and a coiled section disposed between the first end and the second end, and a balloon comprising a wall and extending radially around at least a portion of the coiled section of the support member, where the balloon defines an inner lumen of the implantable device.
  • the balloon is movable from a delivery configuration to a deployed configuration, where the inner lumen has a first inner diameter in the delivery configuration and a second inner diameter in the deployed configuration, the second inner diameter being smaller than the first inner diameter.
  • an implantable device for treating regurgitation in a native heart valve comprises a support member comprising a first end, a second end, and a coiled section disposed between the first end and the second end, and an expandable member extending radially around at least of portion of the coiled section of the support member, where the expandable member defines an inner lumen of the implantable device.
  • the expandable member is movable from a delivery configuration to a deployed configuration, where the inner lumen has a first inner diameter in the delivery configuration and a second inner diameter in the deployed configuration, the second inner diameter being smaller than the first inner diameter.
  • an implantable device for treating regurgitation in a native heart valve comprises one or more of the acts or components recited in Examples 1-19 below.
  • a method of reducing regurgitation through a native heart valve can comprise positioning an implantable device around native valve leaflets, native chordae tendineae, or both the native valve leaflets and the native chordae tendineae of the native heart valve.
  • the method of reducing regurgitation through a native heart valve can further comprise one or more of the steps disclosed herein.
  • the implantable device can be in a delivery configuration and can comprise a support member comprising a first end, a second end, and a coiled section disposed between the first end and the second end.
  • the implantable device can comprise an expandable member extending radially around at least a portion of the coiled section of the support member and defining an inner lumen of the implantable device, where the inner lumen can have a first diameter in the delivery configuration.
  • the method can further comprise expanding the expandable member from the delivery configuration to a deployed configuration, where the inner lumen can comprise a second diameter in the deployed configuration.
  • the second diameter can be smaller than the first diameter such that the expandable member can urge the native leaflets inwardly and reduce regurgitation through the native heart valve.
  • the method can further comprise adjusting the second diameter to vary an inward radial force applied to the native valve to alter tension within the native valve Attorney Docket No: THVMC-23550WO01 leaflets, the native chordae tendineae, or both the native valve leaflets and the native chordae tendineae to reduce regurgitation.
  • the expandable member can comprise an inflatable balloon.
  • the method can further comprise attaching an inflation tube to an inflation port extending through a balloon wall to add or remove a fluid within the balloon.
  • the method can further comprise using the inflation tube to adjust a volume of the fluid within the balloon to vary the second diameter.
  • the method can further comprise inserting a prosthetic heart valve within an annulus of the native heart valve as part of a subsequent procedure, where the coiled section of the support member and the balloon can encircle the native heart valve and the prosthetic heart valve.
  • the method can further comprise deflating the balloon before inserting the prosthetic heart valve within the annulus.
  • the method can further comprise expanding the balloon after inserting the prosthetic heart valve, where the second diameter can be configured to cooperate with the prosthetic heart valve to secure the prosthetic valve in place.
  • the expandable member can further comprise a second balloon and the method can further comprise attaching a second inflation tube to a second inflation port extending through a second balloon wall to add or remove a fluid within the second balloon.
  • the method can further comprise using the second inflation tube to adjust a volume of the fluid within the second balloon to vary a third diameter.
  • the expandable member can comprise a braid.
  • the method can further comprise inserting a prosthetic heart valve within the annulus of the native heart valve as part of a subsequent procedure, where the coiled section of the support member and the braid can encircle the native heart valve and cooperate with the prosthetic heart valve within the annulus to secure the prosthetic valve in place.
  • the method can further comprise relaxing the braid before inserting the prosthetic heart valve into the annulus.
  • the method can further comprise expanding the braid after inserting the prosthetic heart valve, where the second diameter can be configured to cooperate with the prosthetic heart valve to secure the prosthetic valve in place.
  • a method of reducing regurgitation through a native heart valve comprises positioning an implantable device around native leaflets native valve leaflets, native chordae tendineae, or both the native valve leaflets and the native chordae tendineae of the native heart valve, where the implantable device is in a delivery configuration and comprises a support member.
  • the support member comprises a first end, a second end, and a coiled section disposed between the first end and the second end and an expandable member extending radially around at least a portion of the coiled section of the support member and defining an inner lumen of the implantable device, where the inner lumen has a first diameter in the delivery configuration.
  • the method further comprises expanding the expandable member from the delivery configuration to a deployed configuration, where the inner lumen comprises a second diameter in the deployed configuration that is smaller than the first diameter such that the expandable member urges the native leaflets inwardly and reduces regurgitation through the native heart valve.
  • a method of reducing regurgitation through a native heart valve comprising one or more of the acts or components recited in Examples 20-35 below.
  • FIG. 1 is a schematic view of an example of a delivery apparatus and an expandable coil device during an implantation procedure within a patient’s native mitral valve.
  • FIG. 2 is a detail view of the heart and the expandable coil device of FIG.
  • FIG. 3 is a perspective view of the expandable coil device of FIG. 2, showing the native valve leaflets and the native chordae tendineae of the native valve from the left ventricle.
  • FIG. 4 is a detail view of the expandable coil device and the native heart valve of FIG. 2 with a balloon inflation tube, before expanding the balloon.
  • FIG. 5 is a perspective view of the expandable coil device with the balloon in a deflated state.
  • FIG. 6 is a cross-sectional view of the expandable coil device of FIG. 5. [0060] FIG.
  • FIG. 7 is a detail view of the expandable coil device and the native heart valve of FIG. 2, after expanding the balloon and before removing the balloon inflation tube.
  • FIG. 8 is a perspective view of the expandable coil device of FIG. 7 with the balloon in an expanded state.
  • FIG. 9 is a cross-sectional view of the expandable coil device of FIG. 8.
  • FIG. 10 is a detail view of the expandable coil device and the native heart valve of FIG. 7, after expanding the balloon and removing the balloon inflation tube.
  • FIG. 11 is a detail view of the native heart valve and an example of an expandable coil device comprising a balloon with various diameters, after expanding the balloon and removing the balloon inflation tube.
  • FIG. 12 is a detail view of the native heart valve and an example of an expandable coil device comprising a plurality of balloons after expanding the balloons and removing balloon inflation tubes.
  • FIG. 13 is a detail view of a native heart valve and an expandable coil device comprising a braid, after inserting the expandable coil device around the native heart valve and before expanding the braid, according to an example.
  • FIG. 14 is a detail view of the native heart valve and the expandable coil device of FIG. 13, after expanding the braid.
  • FIG. 15 is a schematic view of an example of delivery and deployment of a prosthetic heart valve within an expandable coil device.
  • FIG. 16 is a side perspective view of a prosthetic heart valve, according to an example.
  • FIG. 17 is a detail view of the native heart in FIG. 15 showing the expandable coil device and the inflation tube of FIG. 4, after deploying the prosthetic heart valve and before expanding the balloon, where the prosthetic valve is shown schematically.
  • FIG. 18 is a detail view of the native heart in FIG. 15 showing the expandable coil device and the inflation tube of FIG. 7, after deploying the prosthetic heart valve and expanding balloon.
  • FIG. 19 is a top view of the expandable coil device of FIG. 18 with the deployed prosthetic heart valve of FIG. 16.
  • proximal refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site.
  • distal refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site.
  • proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the patient’s body).
  • longitudinal and axial refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.
  • the devices and methods can be used to repair or replace a native valve suffering from regurgitation.
  • the native valve can be a native mitral valve.
  • the native valve can be a native aortic valve, a native tricuspid valve, or a native pulmonary valve.
  • an expandable coil device 10 also referred to herein as a “coil device” or an “implantable device”
  • the coil device 10 comprises an expandable member, according to an example.
  • a user delivers and implants the expandable coil device around a patient’s native heart valve using a coil delivery apparatus.
  • FIG. 1 depicts a portion of the implantation procedure where the expandable coil device 10 is being implanted at a mitral valve 12 (also referred to herein as a “valve”) of a heart 14 of a patient 16 using a delivery apparatus 18 (which may also be referred to herein as “catheter” and/or “delivery device”).
  • a mitral valve 12 also referred to herein as a “valve”
  • a delivery apparatus 18 which may also be referred to herein as “catheter” and/or “delivery device”.
  • the delivery apparatus 18 comprises a delivery shaft 20, a handle 22, and a pusher assembly 24.
  • the delivery apparatus comprises an inflation assembly 25 comprising an inflation tube 27.
  • the delivery shaft 20 is configured to extend into the patient’s vasculature and provide a passageway for the coil device 10 to reach the implantation site (e.g., the mitral valve 12, in an example). Specifically, the delivery shaft 20 may be configured to be advanced through the patient’s vasculature to the implantation site and may be configured to receive and/or retain the coil device 10 therein. In some examples, the delivery shaft 20 may comprise an outer sheath or shaft that defines a lumen. The pusher assembly 24, the inflation tube 27, and/or the coil device 10 may be configured to be received and/or advanced within the lumen of the delivery shaft 20.
  • the handle 22 is configured to be gripped and/or otherwise held by the user to advance the delivery shaft 20 through the patient’s vasculature.
  • the handle 22 is coupled to a proximal end 26 of the delivery shaft 20 and is configured to remain accessible to the user (e.g., outside the patient 16) during the coil implantation procedure. In this way, the user can advance the delivery shaft 20 through the patient’s vasculature by exerting a force on (e.g., pushing) the handle 22.
  • the delivery shaft 20 may be configured to carry the pusher assembly 24, the inflation tube 27, and/or the coil device 10 with it as it advances through the patient’s vasculature.
  • the coil device 10, the inflation tube 27, and/or the pusher assembly 24 may move through the patient’s vasculature together with the delivery shaft 20 as the user grips the handle 22 and manipulates the delivery shaft 20 through the patient’s vasculature.
  • the various devices can be moved separately.
  • the inflation assembly 25 in the delivery apparatus 18 comprises a connector or fitting 29 adjacent to the handle 22.
  • the inflation tube 27 extends from the fitting 29, through the handle 22, and into the delivery shaft 20.
  • a distal end of the inflation tube 27 is coupled to the coil device 10 and the inflation tube 27 can travel with the coil device 10 as it is advanced through the patient’s vasculature by the delivery shaft 20.
  • the inflation assembly 25 is coupled to a hose 31.
  • the hose 31 can, in some instances, be fluidly Attorney Docket No: THVMC-23550WO01 connected to a fluid reservoir.
  • the fluid reservoir can, for example, provide a fluid source for inflation fluid.
  • the handle 22 may comprise one or more articulation members 28 that are configured to aid in navigating the delivery shaft 20 through the patient’s vasculature.
  • the articulation members 28 may comprise one or more of knobs, buttons, wheels, and/or other types of physically adjustable control members that are configured to be adjusted by the user to flex, bend, twist, turn, and/or otherwise articulate a distal end 30 of the delivery shaft 20 to aid in navigating the delivery shaft 20 through the patient’s vasculature.
  • the pusher assembly 24 is configured to deploy and/or implant the coil device 10 at the implantation site (e.g., native valve). Specifically, the pusher assembly 24 is configured to be adjusted by the user to advance the coil device 10 and the inflation tube 27 through the delivery shaft 20 and push the coil device 10 out of the distal end 30 of the delivery shaft 20.
  • the pusher assembly 24 may be configured to extend through the delivery shaft 20, within the lumen defined by the outer sheath of the delivery shaft 20.
  • the pusher assembly 24 also may be coupled to the coil device 10 such that the pusher assembly 24 pushes the coil device 10 through and/or out of the delivery shaft 20 as the pusher assembly 24 advances through the delivery shaft 20.
  • the coil device 10 may advance in lockstep with the pusher assembly 24 through and/or out of the delivery shaft 20.
  • the pusher assembly 24 comprises a pusher shaft 32 configured to advance the coil device 10 through the delivery shaft 20 and out of the distal end 30 of the delivery shaft 20.
  • the pusher shaft 32 advances through the delivery shaft alongside and parallel to the inflation tube 27. Specifically, the pusher shaft 32 pushes the coil device 10 out of the delivery shaft 20 and positions the coil device 10 at the implantation site.
  • the pusher assembly 24 may comprise a pusher handle 36 (which may also be referred to herein as “hub assembly 36”) that is coupled to the pusher shaft 32 and that is configured to be gripped and pushed by the user to translate the pusher shaft 32 axially relative Attorney Docket No: THVMC-23550WO01 to the delivery shaft 20 (e.g., to push the pusher shaft 32 into and/or out of the distal end 30 of the delivery shaft 20).
  • the pusher assembly 24 may be removably coupled to the coil device 10 and as such may be configured to release, detach, decouple, and/or otherwise disconnect from the coil device 10 once the coil device 10 has been deployed at the implantation site, leaving the inflation tube 27 still attached to the coil device 10.
  • the pusher assembly 24 e.g., pusher shaft 32
  • the pusher assembly 24 may be removably coupled to the coil device 10 via a thread, string, yarn, suture, or other suitable material that is tied or sutured to the coil device 10.
  • the pusher assembly 24 comprises a suture lock assembly 40 that is configured to receive and/or hold the thread or other suitable material that is coupled to the coil device 10 via the suture.
  • the thread or other suitable material that forms the suture may extend from the coil device 10, through the pusher assembly 24, to the suture lock assembly 40.
  • the suture lock assembly 40 may also be configured to cut the thread to release, detach, decouple, and/or otherwise disconnect the coil device 10 from the pusher assembly 24.
  • the suture lock assembly 40 may comprise a cutting mechanism that is configured to be adjusted by the user to cut the thread.
  • the blood vessel 42 may be a femoral vein.
  • the user may insert an introducer device 44, a guidewire 46, and/or other devices (e.g., the delivery shaft 20, inflation tube 27, and/or pusher shaft 32 of the coil delivery apparatus 18, catheters, and/or other delivery apparatuses, coil device 10, prosthetic valves, etc.) through the incision and into the blood vessel 42.
  • the introducer device 44 (which can include an introducer sheath, not shown in FIG.
  • the guidewire 46 is configured to facilitate the percutaneous introduction of the guidewire 46 and/or the other devices (e.g., coil delivery apparatus 18) into and through the blood vessel 42 and may extend through only a Attorney Docket No: THVMC-23550WO01 portion of the blood vessel 42 even when it is fully inserted by the user (i.e., it may extend through the blood vessel 42 towards the heart 14, but may stop short of the heart 14).
  • the guidewire 46 on the other hand, is configured to guide the delivery apparatuses (e.g., the coil delivery apparatus 18, prosthetic valve delivery apparatuses, catheters, etc.) and their associated devices (e.g.
  • the user may advance the guidewire 46 through the blood vessel 42 (e.g., through the femoral vein and inferior vena cava) to a right atrium 52 of the heart 14.
  • the user may make a small incision in an atrial septum 54 of the heart 14 to allow the guidewire 46 to pass from the right atrium 52 to the left atrium 50 of the heart 14 and may then advance the guidewire 46 through the incision in the atrial septum 54 into the left atrium 50.
  • the guidewire 46 may provide a pathway that the coil delivery apparatus 18 can follow as it advances through the patient’s vasculature to ensure that the coil delivery apparatus 18 does not perforate the walls of the blood vessel 42 and/or other vasculature tissue.
  • the user may insert the coil delivery apparatus 18 (e.g., the delivery shaft 20) into the patient 16 by advancing the coil delivery apparatus 18 through the introducer device 44 and over the guidewire 46. The user may continue to advance the coil delivery apparatus 18 through the patient’s vasculature along the guidewire 46 until the coil delivery apparatus 18 reaches the left atrium 50, as illustrated in FIG. 1.
  • the user may advance the delivery shaft 20 of the coil delivery apparatus 18 by gripping and exerting a force on (e.g., pushing) the handle 22 of the coil delivery apparatus 18. While advancing the delivery shaft 20 through the patient’s vasculature, the user may adjust the one or more articulation members 28 of the handle 22 to navigate the various turns, corners, constrictions, and/or other obstacles in the patient’s vasculature. [0094] Once the delivery shaft 20 reaches the left atrium 50, the user may position the distal end 30 of the delivery shaft 20 at and/or near the posteromedial commissure of the mitral valve 12 using the handle 22 (e.g., the articulation members 28).
  • the user may then push the coil device Attorney Docket No: THVMC-23550WO01 10 with the inflation tube 27 attached out of the distal end 30 of the delivery shaft 20 with the pusher assembly 24 to deploy and/or implant the coil device 10 at the native valve 12.
  • the user may actuate the pusher handle 36 to axially translate the pusher shaft 32, in a distal direction, relative to the delivery shaft 20, such that the coil device 10 is deployed out of the delivery shaft 20 and moved into a desired position at the implantation site as shown in the detail view of FIG. 2.
  • the coil device 10 may comprise a filament (also referred to herein as a “support member,” “wire,” or “core”) comprising a first end, a second end, and a coiled section disposed between the first end and the second end.
  • the coil device 10 can further include an inflatable or expandable member surrounding at least a portion of the filament.
  • the inflatable or expandable member can surround at least a portion of the coiled section of the filament.
  • the filament may be constructed from, formed of, and/or comprise an elastic and/or shape memory material (e.g., Nitinol). As such, the filament can be shape set in its helical (e.g., coiled) form (see e.g., FIG.
  • the filament can be straightened and/or bent into other shapes.
  • the filament can return to its original, pre-formed shape (e.g., a coil or helical shape) when it exits the delivery shaft 20 and is no longer constrained by the delivery shaft 20.
  • the filament of the coil device 10 may originally be formed as a coil, and thus may wrap around the ventricular side of the native leaflets and the native chordae tendineae as shown in a perspective view from the left ventricle in FIG. 3 as the coil device 10 exits the delivery shaft 20 and returns to its original coiled configuration.
  • the user may then release the coil device 10 from the delivery shaft 20 within the left atrium 50, leaving the inflation tube 27 still coupled to the coil device 10 as shown in FIG. 4. Specifically, the user may retract the delivery shaft 20 relative to the coil device 10, away from the posteromedial commissure of the mitral valve 12.
  • the user may maintain the position of the pusher shaft 32 (e.g., by exerting a holding and/or pushing force Attorney Docket No: THVMC-23550WO01 on the pusher shaft 32) while retracting the delivery shaft 20 so that the delivery shaft 20 withdraws and/or otherwise retracts relative to the coil device 10 and the pusher shaft 32.
  • the pusher shaft 32 may hold the coil device 10 in place while the user retracts the delivery shaft 20, thereby releasing the coil device 10 from the delivery shaft 20.
  • the user may decouple and/or otherwise disconnect the coil delivery apparatus 18 from the coil device 10 by, for example, cutting the thread that is sutured to the coil device 10.
  • the user may cut the thread with the cutting mechanism of the suture lock assembly 40, leaving the inflation tube 27 intact and attached to the coil device 10.
  • the coil device 10 is advanced through the delivery shaft 20 into position surrounding the valve leaflets in the left ventricle 56 without the inflation tube 27 attached.
  • the inflation tube 27 can be advanced through the delivery shaft 20 in a subsequent step and attached to the implanted coil device 10 at that time.
  • Additional information regarding exemplary delivery apparatus for implanting a coil device can be found, for example, in International Publication No. WO 2020/247907, which is incorporated by reference herein. [0100]
  • FIG. 4 is a detail view of the coil device 10 and the inflation tube 27 of FIG. 2 after the coil device 10 is released within the left ventricle 56 and into position surrounding the native valve leaflets 58, the native chordae tendineae 60, or both the native valve leaflets 58 and the native chordae tendineae 60.
  • the native valve leaflets 58 are shown for simplicity in FIG. 4 in cross-section.
  • the coil device 10 comprises an expandable member in the form of an inflatable balloon assembly 62 (also referred to herein as a “balloon assembly” or a “balloon”), for example, shown in a delivery configuration in FIG. 4.
  • the coil device 10 and the balloon assembly 62 are shown in FIG. 5 without the native valve structure for clarity.
  • the coil device 10 deploys within the left ventricle 56 into a coil shape surrounding the native valve leaflets 58 and/or the native chordae Attorney Docket No: THVMC-23550WO01 tendineae 60.
  • the coil shape with the expandable member of the coil device 10 defines an inner lumen L shown in the delivery configuration in FIG. 5.
  • the filament 64 has a first end, a second end, and a coiled section disposed between the first and second ends.
  • the balloon assembly 62 has an outermost surface 66 and is configured to extend radially around the filament 64 in at least a portion of the coiled section of the filament 64. In some examples, the balloon assembly 62 extends from the first end of the filament 64 to the second end of the filament 64, as shown in FIG. 5.
  • the inner lumen L of the coil device 10 has a first inner diameter D1 in the delivery or non-inflated configuration (see, e.g., FIGS. 4-5).
  • the first inner diameter D1 (also referred to herein as a “delivery diameter”) is defined as a distance between diametrically opposing inner points within the inner lumen L.
  • the inflatable balloon assembly 62 comprises a distal end 68 and a proximal end 70.
  • FIG. 5 depicts a perspective view
  • FIG. 6 depicts a cross-sectional view of the coil device 10.
  • the outermost surface 66 of the balloon assembly 62 surrounds the filament 64 and defines a first outer diameter D2, which corresponds to the delivery or non- inflated configuration.
  • the outermost surface 66 of the balloon assembly 62 defines both the first outer diameter D2 and the first inner diameter D1 of the lumen L.
  • the balloon assembly 62 comprises an inner, radial surface 72 that contacts and attaches to an outer, radial surface 74 of the filament 64 along an interface 76.
  • the interface 76 extends along the balloon assembly 62 from the distal end 68 of the balloon assembly 62 to the proximal end 70 of the balloon assembly 62.
  • the inner, radial surface 72 of the balloon assembly 62 can be bonded or otherwise secured to the outer, radial surface 74 of the filament 64 along the interface 76 or portions of the interface 76.
  • the balloon assembly 62 comprises a balloon wall.
  • the balloon wall can comprise a plurality of layers including an inner balloon layer 78a (also referred to herein as an “inner wall” or “inner layer”) and an outer balloon layer 78b (also referred to herein as an “outer wall” or “outer layer”) as shown in FIG. 6.
  • the inner and outer layers 78a, 78b can comprise a material that is flexible, resilient, and strong such as, for example, silicone, a thermoplastic polyurethane (TPU), polyamide, co-polyamide, polyethylene (PET), polyethylene terephthalate, expanded polytetrafluoroethylene (ePTFE), polybutylene terephthalate, thermoplastic elastomer copolyester, or combinations thereof.
  • the balloon material can be consistent throughout the balloon assembly 62 from the distal end 68 to the proximal end 70 of the balloon assembly 62 to ensure even inflation and expansion.
  • the balloon material can vary between the distal and proximal ends 68, 70 to vary expansion, as will be described later herein in reference to FIGS. 11-12.
  • the inner and outer balloon layers 78a, 78b can be secured to each other at the distal and proximal ends 68, 70 of the balloon assembly 62.
  • the inner and outer layers 78a, 78b can be radially coupled to each other by bonding, heat sealing, or any other means for coupling and sealing.
  • the inner and outer balloon layers 78a, 78b can be unattached from each other and arranged to form a space or cavity 80 therebetween to accommodate an inflation fluid.
  • the cavity 80 can extend radially around the filament 64 symmetrically.
  • the cavity 80 can be arranged asymmetrically on radial portions of the filament 64.
  • the cavity can be arranged on radial portions of the filament 64 defining the inner diameter of the lumen L.
  • a radially asymmetric cavity 80 can be configured to cause radially inward inflation of the coil device 10 into the lumen L while an outer surface of the coil device 10 remains unchanged.
  • the balloon assembly 62 can comprise one or more additional components and/or layers.
  • the balloon assembly 62 can further comprise an outer Attorney Docket No: THVMC-23550WO01 cover 82 extending over at least a portion of the outer balloon layer 78b between the distal and proximal ends 68, 70 of the balloon assembly 62.
  • the outer cover 82 can comprise a fabric, a coating, or combinations thereof.
  • the outer cover 82 can be arranged over the outer balloon layer 78b or over portions of the outer balloon layer 78b.
  • the outer cover 82 can provide a frictional surface against which the native heart structure can interface during deployment and expansion.
  • the outer cover 82 can promote tissue ingrowth and visualization under different imaging modalities, in some instances.
  • the balloon assembly 62 can comprise additional layers including inner layers disposed between the inner, radial surface 72 of the balloon assembly 62 and the outer, radial surface 74 of the filament 64.
  • the balloon assembly 62 can comprise radially uneven layers, where layers can vary in thickness around a radius of the balloon assembly 62.
  • layers can be disposed around portions of a radius of the balloon assembly 62.
  • the outermost surface 66 of the balloon assembly 62 defines both the outer diameter D2 and the inner lumen diameter D1.
  • the balloon assembly 62 further includes an inflation port 84 at the proximal end 70, where the inflation port 84 can extend through the proximal end 70 of the balloon assembly 62, a sidewall of the balloon assembly 62 adjacent to the proximal end 70, or through a sidewall of the balloon assembly 62 at locations between the distal and proximal ends 68, 70 with user access.
  • the inflation port 84 can comprise an opening extending through at least a portion of the balloon assembly 62. In the example of FIGS. 5-6, the inflation port 84 extends through the outer cover 82 and the outer wall 78b, providing fluid access between the inflation tube 27 and the cavity 80 for inflation.
  • the inflation port 84 can comprise any fitting or interface including, for example, a barbed fitting, a luer fitting, a snap fitting, a self-sealing cover or any other fluid fitting known in the art to which the inflation tube 27 can couple without leaking.
  • the fitting or interface between the inflation port 84 and the inflation tube 27 can be configured for a one-time connection or repeat connections.
  • FIG. 7 shows a detail view of the balloon assembly 62 in a deployed configuration with the native valve 12.
  • FIG. 8 shows a perspective view of the balloon assembly 62 in the deployed configuration without the native valve 12 for clarity.
  • the user can inject fluid through the inflation tube 27 and the inflation port 84, filling the cavity 80 between the inner and outer balloon layers 78a, 78b.
  • FIG. 9 shows the coil device 10 of FIG.
  • the inflation fluid 86 can comprise any bio-compatible and/or bio-safe fluid including saline, a foaming fluid, a self-hardening fluid, a radiopaque fluid, or a combination thereof.
  • the real-time injection of the inflation fluid 86 and the second outer diameter D4 during and after expansion can be monitored, providing the user with visibility into the size and shape of the balloon assembly 62 (and the coil device 10) during deployment.
  • radiopaque markers can be included on layers of the balloon assembly 62 to allow the user to monitor the size and shape of the balloon assembly 62 (and the coil device 10) during inflation, with or without a radiopaque inflation fluid.
  • This real-time, visual feedback can allow the user to adjust the second outer diameter D4 by increasing or decreasing the amount of inflation fluid 86 within the cavity 80 until a desired, second outer diameter D4 is achieved.
  • a second inner diameter D3 (also referred to herein as a “deployed diameter”) of the lumen L is shown in FIG. 8.
  • the deployed diameter D3 is smaller than the delivery diameter D1 of FIG. 5.
  • the deployed diameter D3 results in an increase in the radially inward force applied on the native heart valve by the coil device 10. This radially inward force squeezes the native valve leaflets 58 and/or the native chordae tendineae 60 in a radially inward direction, creating tension in the native valve 12.
  • An increase in tension in the native valve 12 can improve native leaflet coaptation and/or close gaps between the native valve leaflets 58, thereby preventing or reducing the likelihood of regurgitation.
  • the inward force and added tension in the native valve leaflets 58 and native chordae tendineae 60 can tighten the native valve leaflets 58 and the chordae tendineae 60, further contributing to a reduction in regurgitation.
  • inflation of the balloon assembly 62 can be monitored in real- time by the user, allowing the user to view the effects of inflation on the native valve leaflets 58 and the native chordae tendineae 60 during inflation. FIGS.
  • first outer diameter D2 and a second outer diameter D4 show a first outer diameter D2 and a second outer diameter D4, but it is understood that the balloon assembly 62 can assume any outer diameter size between a minimum diameter and a maximum diameter, where the maximum diameter can be specified to prevent excessive tension applied to the native chordae tendineae 60 during inflation.
  • the user can observe operation of the native valve 12, including any reduction in regurgitation, and vary a volume of inflation fluid 86 within the balloon assembly 62 to adjust the radially inward force applied to the native valve leaflets 58 and/or the native chordae tendineae 60, thereby optimizing valve function.
  • the inflation port 84 can comprise a valve element that engages when the inflation tube 27 is removed, such that the valve closes the inflation port 84 and prevents fluid ingress or egress therethrough.
  • the inflation port 84 comprises a self-sealing cover that, when the inflation tube is Attorney Docket No: THVMC-23550WO01 removed, seals any aperture, preventing leakage.
  • the expandable member of the coil device 10 can comprise other balloon configurations. In some instances, it may be desirable to adjust the coil device 10 to fit with a particular anatomy of a patient, where patient anatomy can vary from patient to patient. It is also possible that a single patient’s anatomy can vary over time. In some examples, a native valve can benefit from increased inward force or reduced inward force in locations of the native valve due to changes in the native valve or installation of other devices, such as prosthetic heart valves.
  • the coil device 10 may be desirable for the coil device 10 to impart varied or non-uniform inward forces on the native valve leaflets 58 and/or the chordae tendineae 60. For example, it may be desirable to impart larger inward forces toward an inflow end of the native valve than at an outflow end of the native valve, or vice versa, by expanding the coil device 10 unevenly or non-uniformly.
  • FIG. 11 illustrates the native heart valve 12, for example a mitral valve, with native valve leaflets 58 and chordae tendineae 60 surrounded by the coil device 10.
  • the coil device 10 defines a lumen L and, according to an example shown in FIG. 11, comprises a balloon assembly 88 with non-uniform expansion.
  • the balloon assembly 88 comprises a single balloon with a lower, outflow segment 90a and an upper, inflow segment 90b.
  • Each of the outflow and inflow segments 90a, 90b extends a length of the coil device 10.
  • the outflow and inflow segments 90a, 90b can transition therebetween gradually along a transition length or can transition in a step-wise manner.
  • the lengths of the outflow and inflow segments 90a, 90b can be the same. In some instances, the length of the outflow segment 90a can be greater than the length of the inflow segment 90b, or vice versa.
  • the lengths of the outflow and inflow segments 90a, 90b and the length of transition therebetween can be specified to suit a native valve configuration.
  • the balloon assembly 88 can comprise a single inflation port 92.
  • the inflation port 92 can extend through an end of the balloon assembly 88 or a sidewall of the Attorney Docket No: THVMC-23550WO01 balloon assembly 88 at a location with user access.
  • the inflation port 92 can comprise any fitting or interface including, for example, a barbed fitting, a luer fitting, a snap fitting, a self- sealing cover or any other fluid fitting known in the art to which an inflation tube can couple without leaking.
  • the inflow segment 90b is configured to have greater expansion than the outflow segment 90a, as seen in FIG 11.
  • An inner diameter of the lumen L at the location of segment 90b after inflation is smaller than an inner diameter of the lumen L after inflation at the location of the segment 90a.
  • the smaller lumen inner diameter results in a greater inward, radial force applied to the native valve 12 by segment 90b than the inward, radial force applied by segment 90a.
  • segment 90a can be configured to have greater expansion instead, resulting in a greater inward radial force at an outflow section of the native valve 12. In this way, different expansions across the balloon assembly 88 can therefore result in different inward radial forces applied to the native valve 12 and can be specified to suit a native valve configuration.
  • the outflow and inflow segments 90a, 90b may comprise different materials which, when inflated, expand differently or at different rates.
  • the outflow segment 90a may comprise a stiffer material that resists expansion while the inflow segment 90b may comprise a looser material or a material with more stretch that allows greater expansion with the same fluid, or vice versa.
  • the outflow and inflow segments 90a and 90b may comprise a different configuration of layers. For instance, the outflow segment 90a can comprise a greater number of layers to resist expansion, while the inflow segment 90b can comprise a fewer number of layers, or vice versa.
  • the materials and/or the layers vary radially around the balloon assembly 88, where sections of the balloon assembly 88 located within the inner lumen L can differ in expansion due to varied materials and/or layers from other sections of the balloon assembly 88.
  • the balloon assembly 88 may comprise more than two segments of varying expansion capability.
  • the balloon assembly 88 can comprise three or more segments of varying expansion. It is therefore possible to configure the balloon assembly 88 with as many segments of varying expansion in as many sections as desired to optimize inward radial forces applied to the native valve.
  • the various segments can transition gradually or can transition in a step-wise manner.
  • the coil device 10 defines lumen L and comprises a lower, outflow balloon assembly 94a (also referred to herein as an “outflow balloon assembly” or a “lower balloon assembly”) with an inflation port 96 and an upper, inflow balloon assembly 94b (also referred to herein as an “inflow balloon assembly” or an “upper balloon assembly”) with an inflation port 98.
  • the outflow and inflow balloon assemblies 94a, 94b are shown separated by a space 100 along the filament 64.
  • the outflow and inflow balloon assemblies 94a, 94b may be in abutment without a space therebetween.
  • the inflation ports 96 and 98 can extend through an end of their respective balloon assemblies or a sidewall of their respective balloon assemblies at a location with user access.
  • the inflation ports 96 and 98 can comprise any fitting or interface including, for example, a barbed fitting, a luer fitting, a snap fitting, a self-sealing cover or any other fluid fitting known in the art to which an inflation tube can couple without leaking.
  • the expansion of the outflow and inflow balloon assemblies 94a, 94b can be varied by adjusting a volume of inflation fluid in each. For example, by filling the inflow balloon assembly 94b with more inflation fluid than the outflow balloon assembly 94a, the inflow balloon assembly 94b can have greater expansion than the outflow balloon assembly 94a. As such, an inner diameter of lumen L at the location of the inflow balloon assembly 94b after inflation can be smaller than an inner diameter of lumen L after inflation at the location of the Attorney Docket No: THVMC-23550WO01 outflow balloon assembly 94a.
  • the smaller lumen inner diameter results in a greater inward, radial force applied to the native valve 12 by the inflow balloon assembly 94b than by the outflow balloon assembly 94a.
  • the outflow balloon assembly 94a can be configured to have greater expansion instead, resulting in a greater inward radial force at an outflow section of the native valve 12. Different expansions across the outflow and inflow balloon assemblies 94a, 94b can therefore result in different inward radial forces applied to the native valve 12 and can be specified to suit a native valve configuration.
  • the outflow and inflow balloon assemblies 94a, 94b can be configured each with varying materials and layers resulting in varied expansion for the same volume of inflation fluid.
  • the coil device 10 may comprise more than two separate balloon assemblies, either separated by spaces therebetween or in abutment, or combinations thereof. Each separate balloon assembly can have an inflation port. It is therefore possible to configure the coil device 10 with as many balloon assemblies as desired to vary and optimize inward radial forces applied to the native valve, from patient to patient, for reduced regurgitation.
  • the coil device 10 can comprise an expandable member with other forms, for example a braid. FIG.
  • the braid assembly 102 is shown in FIG. 13 in a delivery configuration (also referred to herein as a “relaxed configuration”).
  • the coil device 10 comprising the braid assembly 102 can be delivered and released in the manner described above in reference to FIGS. 1-3, without the inflation tube 27, inflation assembly 25, hose 31, or fluid reservoir.
  • the braid assembly 102 may comprise a braided structure (also referred to herein as a “braid”), such as a braided wire mesh or lattice. [0131] In some examples, not shown in FIGS.
  • the braid assembly 102 can comprise a cover extending over the braided structure or at least a portion of the braided structure of the Attorney Docket No: THVMC-23550WO01 braid assembly 102.
  • the cover can comprise a fabric, a coating, or combinations thereof.
  • the cover can be arranged over the braided structure or over portions of the braided structure to provide a frictional surface against which the native heart structure can interface during deployment and expansion.
  • the outer cover can promote tissue ingrowth and visualization under different imaging modalities, in some instances.
  • the braid assembly 102 may comprise inner layers, where the inner layers can be arranged underneath the braided structure or underneath portions of the braided structure.
  • the inner layers may aid in deployment, reduce friction, or help in manufacturing the braid assembly 102, for example.
  • the inner layer(s) can comprise various materials, including polyethylene, expanded polytetrafluoroethylene (ePTFE), and/or biocompatible materials.
  • the braid assembly 102 in an example, may have a braided structure comprising a metal alloy with shape memory properties, such as Nitinol. As previously described with respect to FIG. 4, the coil device 10 deploys within the left ventricle 56 into a coil surrounding the native valve leaflets 58 and/or the native chordae tendineae 60 due to the shape-memory filament 64 within.
  • the coil shape and the braid assembly 102 of the coil device 10 defines an inner lumen L shown in the delivery configuration in FIG. 13.
  • the braid assembly 102 has an outermost surface 104, which can be an outer surface of the cover (e.g., PET fabric) if included or an outer surface of the braided structure.
  • the outermost surface 104 defines both a first outer diameter D7 of the braid assembly 102 and an inner diameter of the lumen L.
  • the inner diameter of lumen L is defined as a distance between diametrically opposing inner points of the braid assembly 102 within the inner lumen L.
  • the first outer diameter D7 and the inner diameter of the lumen L are inversely related. In other words, when the first outer diameter D7 of the braid assembly 102 increases due to expansion, as will be described later herein, the inner diameter of the lumen L decreases.
  • the braid assembly 102 is configured to extend radially around the filament 64 in at least a portion of the coiled section of the coil device 10 and the filament 64.
  • the braid assembly Attorney Docket No: THVMC-23550WO01 102 of FIG. 13 comprises a distal end portion 106 (also referred to herein as a “first end portion”) and a proximal end portion 108 (also referred to herein as a “second end portion”).
  • the braid assembly 102 can extend from the first end of the filament 64 to the second end of the filament 64.
  • the braid assembly 102 can extend between a portion of the filament 64 between the first and second ends of the filament 64.
  • the braid assembly 102 can be coupled to the filament 64 at its distal end portion 106 using methods known in the art such as one or more of bonding, crimping, stitching, and/or other means for coupling.
  • methods known in the art such as one or more of bonding, crimping, stitching, and/or other means for coupling.
  • International Publication No. WO 2022/087336 which is incorporated by reference herein, describes various exemplary ways to attach a braided sleeve to a coiled filament.
  • the braid assembly 102 may be coupled, fixedly attached and/or otherwise permanently secured to the filament 64 at its distal end portion 106.
  • the proximal end portion 108 can move along the filament 64 in a manner that will be discussed later herein.
  • the braid assembly 102 may be tapered at and/or proximate to the distal end portion 106. That is, the braid assembly 102 may narrow (extend radially inwardly towards the filament 64) near and/or at the distal end portion 106. For instance, the braid assembly 102 may be narrowest at the distal end portion 106, such that the distal end portion 106 is narrower than the rest of the braid assembly 102.
  • the braid assembly 102 may be tapered at and/or proximate to the proximal end portion 108, narrowing radially inward towards the filament 64. In some examples, both the distal and proximal end portions 106, 108 may be tapered at and/or proximate to their respective ends.
  • the braid assembly 102 can comprise means for translating the proximal end portion 108 along the filament 64 for expansion.
  • International Publication No. WO Attorney Docket No: THVMC-23550WO01 2022/087336 which is incorporated by reference herein, describes exemplary means for translating and expanding braided sleeves around a coiled filament.
  • a translation mechanism 109 can be situated at the proximal end portion 108 of the braid assembly 102, for example.
  • the translation mechanism 109 can provide means for translating the proximal end portion 108 of the braid assembly 102 along the filament 64 in a controlled manner.
  • the translation mechanism 109 can also provide means for locking the proximal end portion 108 in position on the filament 64.
  • the translation mechanism 109 is bonded, crimped, stitched, and/or otherwise mechanically coupled to both the proximal end portion 108 of the braid assembly 102 and the filament 64.
  • the translation mechanism 109 comprises interfacing features between the proximal end portion 108 of the braid assembly 102 and the filament 64.
  • the interfacing features can be integrally formed into the proximal end portion 108 of the braid assembly 102 and/or the filament 64.
  • the interfacing features can control translation and positional locking between the proximal end portion 108 of the braid assembly 102 and the filament 64.
  • the translation mechanism 109 comprises frictional elements located between the proximal end portion 108 of the braid assembly 102 and the filament 64. The frictional elements can impede movement of the proximal end portion 108 of the braid assembly 102 on the filament 64 and retain the proximal end portion 108 in place on the filament 64.
  • a pusher shaft can couple to the translation mechanism 109.
  • the user can push the proximal end portion 108 of the braid assembly 102 toward the distal end portion 106 with the pusher shaft, translating the proximal end portion 108 along the filament 64 and expanding the braid assembly 102.
  • the user can pull the pusher shaft, moving the proximal end portion 108 away from the distal end portion 106 to relax the braid assembly 102.
  • the pusher shaft can be decoupled from the translation mechanism 109. The pusher shaft can be recoupled for subsequent pushing/pulling.
  • the translation mechanism 109 can comprise a lead screw mechanism with interfacing threaded features that, when actuated, allow the proximal end portion 108 of the braid assembly 102 to translate along the filament 64.
  • the user can couple a tool to the translation mechanism 109, where the tool engages the lead screw mechanism to translate the proximal end portion 108 along the filament 64.
  • the tool can be decoupled from the translation mechanism 109.
  • the threaded features retain the proximal end portion 108 in place on the filament 64.
  • the pusher shaft can be recoupled for subsequent repositioning.
  • the translation mechanism 109 can comprise a ratcheting mechanism with interfacing teeth that provide incremental translation and locking between the proximal end portion 108 of the braid assembly 102 and the filament 64.
  • the user can couple a tool to the translation mechanism 109, where the tool engages the ratcheting mechanism to translate the proximal end portion 108 along the filament 64. After achieving the desired expansion, the tool can be decoupled from the translation mechanism 109.
  • the interfacing teeth retain the proximal end portion 108 in place on the filament 64. The tool can be recoupled for subsequent repositioning.
  • the translation of the proximal end portion 108 can be continuous along the filament 64.
  • the translation of the proximal end portion 108 can be incremental or step- wise along the filament 64.
  • the proximal end portion 108 of the braid assembly 102 which can translate due to the translation mechanism 109, is moved axially along the filament 64 toward the distal end portion 106, which is held in place, the braided structure is longitudinally/axially compressed (i.e., shortened).
  • the braided structure of the braid assembly 102 is configured to expand radially. The radial expansion of the braid assembly 102 is determined by the displacement of the proximal end portion 108 along the filament 64 and the construction of the braided structure.
  • FIG. 14 shows the braid assembly 102 of FIG. 13 in an expanded and deployed configuration.
  • FIG. 14 illustrates an axial foreshortening of the braid assembly 102 after the second end portion 108 is translated toward the first end portion 106 by the translation mechanism 109.
  • the first end portion 106 of the braid assembly 102 is shown in a same location on the filament 64 in FIGS. 13-14 while the second end portion 108 is shown in FIG. 14 as longitudinally displaced from its position in FIG. 13.
  • the braid assembly 102 in the deployed configuration of FIG. 14 has a second outer diameter D8 that is greater than the first outer diameter D7 of the braid assembly 102 in the relaxed configuration of FIG. 13.
  • the second outer diameter D8 increases, resulting in a decrease in the inner diameter of the lumen L.
  • the decrease in lumen L diameter results in an increase in the radially inward force on the native heart valve provided by the coil device 10. This radially inward force squeezes the native valve leaflets 58 and/or the native chordae tendineae 60 in a radially inward direction, creating tension in the native valve 12.
  • portions of the braid assembly 102 may comprise features for monitoring expansion in real-time, for example, radiopaque markers. During deployment, the user can monitor the expansion of diameter D8 along with the function of the native heart valve 12. This real-time feedback allows the user to adjust expansion of the braid assembly 102 during the procedure using the translation mechanism 109.
  • the translation mechanism 109 can be engaged to translate the proximal end portion 108 further toward the distal end portion 106, thereby increasing braid compression Attorney Docket No: THVMC-23550WO01 and expansion. Conversely, if the native valve 12 requires less tension, the translation mechanism 109 can be engaged to translate the proximal end portion 108 away from the distal end portion 106, thereby relaxing the braid. Once the diameter D8 of the braid assembly 102b is optimized for valve function, the position of the proximal end portion 108 can be locked in place. FIGS.
  • a braid assembly can comprise a braid structure with segments of varying wire mesh or lattice configurations.
  • a braid assembly can comprise a braid structure with segments of varying materials. As previously described, some braided wire mesh or lattice configurations may result in greater radial expansion for a given axial displacement and longitudinal compression than other braided wire mesh or lattice configurations.
  • the coil device 10 can comprise a plurality of braid assemblies either positioned in abutment or separated by a gap along the filament 64.
  • the plurality of braid assemblies may be expanded at the same time.
  • each braid assembly may comprise its own translation mechanism and the plurality of braid assemblies may be expanded independently.
  • each braid assembly with its own translation mechanism can allow the user to adjust expansion of each braid assembly independently and therefore the inward radial forces applied to the native valve 12 by each braid assembly. It is therefore possible to configure the coil device 10 with as many braid assemblies as desired and with braid structures comprising segments of varied wire mesh or lattice configurations and/or varied materials, to enable the user Attorney Docket No: THVMC-23550WO01 to vary expansion and optimize inward radial forces applied to the native valve 12, from patient to patient, for reduced regurgitation. [0152] A patient’s anatomy and heart function can vary over time such that a native valve may require more inward force applied or less inward force applied to reduce regurgitation.
  • FIG. 15 is a schematic view showing delivery and deployment of a prosthetic heart valve during a subsequent procedure, for example, in the patient 16 of FIG. 1.
  • FIG. 15 is a schematic view showing delivery and deployment of a prosthetic heart valve during a subsequent procedure, for example, in the patient 16 of FIG. 1.
  • FIG. 15 shows the coil device 10 already deployed around the native valve 12, according to an example.
  • a user is delivering and/or implanting a prosthetic heart valve 110 (which may also be referred to herein as “transcatheter heart valve” or “THV” for short, “replacement heart valve,” and/or “prosthetic mitral valve”) within a native annulus of the native valve 12 using a prosthetic heart valve delivery apparatus 112.
  • a prosthetic heart valve 110 which may also be referred to herein as “transcatheter heart valve” or “THV” for short, “replacement heart valve,” and/or “prosthetic mitral valve”
  • the coil device 10 and prosthetic heart valve 110 may be delivered on different delivery apparatuses in different native valve repair and replacement procedures.
  • the coil device 10 may be delivered to the native valve 12 with the delivery apparatus 18 during a first procedure and the prosthetic heart valve 110 may then be delivered with the prosthetic heart valve delivery apparatus 112 in a second, later procedure.
  • the prosthetic heart valve delivery apparatus 112 comprises a delivery shaft 114 and a handle 116 coupled to a proximal end 118 of the delivery shaft 114.
  • the delivery shaft 114 is configured to extend into the patient’s vasculature to deliver, implant, expand, and/or otherwise deploy the prosthetic heart valve 110 within the coil device 10 at the native valve 12.
  • the handle Attorney Docket No: THVMC-23550WO01 116 may be the same as, or similar to, the handle 22 of the delivery apparatus 18 and is similarly configured to be gripped and/or otherwise held by the user to advance the delivery shaft 114 through the patient’s vasculature.
  • the handle 116 may comprise one or more articulation members 120 that are configured to aid in navigating the delivery shaft 114 through the patient’s vasculature.
  • the articulation members 120 may comprise one or more of knobs, buttons, wheels, and/or other types of physically adjustable control members that are configured to be adjusted by the user to flex, bend, twist, turn, and/or otherwise articulate a distal end 122 of the delivery shaft 114 to aid in navigating the delivery shaft 114 through the patient’s vasculature.
  • the prosthetic heart valve delivery apparatus 112 may comprise an expansion mechanism 124 that is configured to radially expand and deploy the prosthetic heart valve 110.
  • the expansion mechanism 124 may comprise an inflatable balloon that is configured to be inflated to radially expand the prosthetic heart valve 110 within the coil device 10.
  • the expansion mechanism 124 may be included in and/or coupled to the delivery shaft 114 at and/or proximate to the distal end 122 of the delivery shaft 114.
  • the prosthetic heart valve 110 may be self-expanding and may be configured to radially expand on its own without the expansion mechanism 124.
  • the prosthetic heart valve 110 may be mechanically expandable and the prosthetic heart valve delivery apparatus 112 can include one or more mechanical actuators configured to radially expand the prosthetic heart valve 110.
  • the prosthetic heart valve 110 may be coupled to the delivery shaft 114 at and/or proximate to the distal end 122 of the delivery shaft 114.
  • the prosthetic heart valve 110 may be mounted on the expansion mechanism 124 in a radially compressed configuration.
  • the prosthetic heart valve 110 may be removably coupled to the delivery shaft 114 such that, after the prosthetic heart valve 110 is radially expanded and deployed from the prosthetic heart valve delivery apparatus 112, the prosthetic heart valve delivery apparatus 112 Attorney Docket No: THVMC-23550WO01 can be retracted away from the implanted prosthetic heart valve 110 and removed from the patient 16.
  • the prosthetic heart valve 110 is configured to be received and/or retained within the native valve 12 and the coil device 10 surrounding the native valve 12 in the left ventricle 56.
  • the coil device 10 and prosthetic heart valve 110 can be used in conjunction with any native valve in the heart.
  • the coil device 10 can be configured to receive the prosthetic heart valve 110 and help anchor or dock the prosthetic heart valve 110 to the native valve 12.
  • the coil device 10 can also be configured to provide a seal between the prosthetic heart valve 110 and the leaflets of the valve to reduce paravalvular leakage around the prosthetic heart valve 110.
  • the coil device 10 may initially constrict the leaflets of the native valve 12.
  • FIG. 16 is a perspective view of the prosthetic heart valve 110 of FIG. 15 in a deployed configuration, according to an example.
  • the prosthetic heart valve 110 can include a stent or frame 126 and a valvular structure 128.
  • the valvular structure 128 can include three leaflets 130, 132, and 134, collectively forming a leaflet structure (although a greater or fewer number of leaflets can be used), which can be arranged to collapse in a tricuspid arrangement.
  • the leaflets 130, 132, and 134 are configured to permit the flow of blood from an inflow end 136 to an outflow end 138 of the prosthetic heart valve 110 and block the flow of blood from the outflow end 138 to the inflow end 136 of the prosthetic heart valve 110.
  • the leaflets 130, 132, and 134 can be secured to one another at their adjacent sides to form commissures 140, 142, and 144 of Attorney Docket No: THVMC-23550WO01 the leaflet structure.
  • the leaflets 130, 132, and 134 can be formed of pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, and/or various other suitable natural or synthetic materials, for example, as described in U.S. Patent No. 6,730,118, which is incorporated by reference herein.
  • the frame 126 can be formed with a plurality of circumferentially spaced slots, or commissure windows that are adapted to mount the commissures 140, 142, and 144 of the valvular structure 128 to the frame 126.
  • the frame 126 can be made of any of various suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol) as known in the art.
  • plastically expandable material e.g., stainless steel, etc.
  • self-expanding materials e.g., Nitinol
  • the frame 126 When constructed of a plastically expandable material, the frame 126 (and thus the prosthetic heart valve 110) can be crimped to a radially compressed state on a delivery apparatus and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism.
  • the frame 126 and thus the prosthetic heart valve 110
  • the frame 126 can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery apparatus.
  • the prosthetic heart valve 110 can be advanced from the delivery sheath, which allows the prosthetic heart valve 110 to expand to its functional size within the annulus of the native valve 12.
  • the deployed prosthetic valve 110 shown in FIG. 16 is representative of any number of prosthetic valves that may be implanted into a native valve in cooperation with the coil device 10. Examples of suitable prosthetic heart valves can be found in U.S. Patent No 9,393,110 (which is incorporated by reference herein) and International Publication No. WO 2020/247907. [0163] Depending on the size of the prosthetic heart valve 110 for deployment within the native valve 12, it may be necessary to first collapse an expandable member of the coil device 10 to increase an inner diameter of the lumen L.
  • an inflation tube can be reattached to an inflation port for fluid removal from a balloon assembly or assemblies.
  • a braid assembly any braid assembly herein, such as the braid assembly 102, for example
  • a translation mechanism any translation mechanism herein, Attorney Docket No: THVMC-23550WO01 such as translation mechanism 109, for example
  • FIG. 17 is a close-up view of the native valve 12 in FIG.
  • the prosthetic heart valve 110 shown schematically in FIG. 17, is illustrated after insertion and expansion to its functional size within the native annulus of the valve 12.
  • the coil device 10 is shown in this example comprising the inflatable balloon assembly 62 in a non-inflated or deflated configuration, although it is understood that any expandable member herein (for example, balloon assemblies 62, 88, 94a, and 94b or braid assembly 102) can be used.
  • the coil device 10 which had been previously deployed surrounding the native valve leaflets 58 and/or the native chordae tendineae 60, is shown in a deflated configuration for installation of the prosthetic heart valve 110.
  • the coil device 10 is shown in FIG.
  • the volume of inflation fluid removed depends on the size of the originally deployed balloon assembly 62 and the prosthetic heart valve 110 inserted. It may be necessary to remove all the inflation fluid within the balloon assembly 62 or only a portion of the inflation fluid. It may be that no inflation fluid needs to be removed.
  • the lumen L of the coil device 10 can be sized so that the coil device 10 remains in place surrounding the native valve 12 and the prosthetic valve 110 can be positioned and expanded within the native annulus to a specified size. [0166] Once the prosthetic valve 110 is positioned and expanded within the native annulus, as shown in FIG. 17, the coil device 10 can be re-expanded or re-inflated. FIG.
  • FIG. 18 shows the expandable coil device 10 and the inflation tube 27 of FIG. 7, after deployment of the prosthetic heart valve 110 and expansion or inflation of the balloon assembly 62.
  • the prosthetic heart valve 110 is shown schematically in FIG. 18 for simplicity.
  • FIG. 19 shows a top view of the coil device 10 of FIG. 18 with the deployed prosthetic heart valve 110 as it is shown in FIG. 16.
  • the balloon assembly 62 can also, for example, provide a seal between the native valve 12 and the prosthetic heart valve 110 (thereby reducing paravalvular leakage around the prosthetic heart valve 110) when in a deployed configuration.
  • Inflation of the balloon assembly 62 can be adjusted to modify a shape and/or size of the balloon assembly 62 such that the balloon assembly (and the coil device 10) can apply radially inward force on the valve and seal openings in the native valve 12, thus reducing paravalvular leakage at and/or near commissures. More specifically, the uppermost ventricular side portion of the coil device 10 may help close and/or otherwise seal openings in the native valve 12 that are present beyond the edges of the prosthetic heart valve 110 (i.e., radially outwardly from the prosthetic heart valve 110).
  • an expandable member (any expandable member herein, such as the balloon assemblies 62, 88, 94a, and 94b, or the braid assembly 102, for example), can be expanded or inflated to a size and shape suited to squeeze the native valve leaflets 58 and/or the chordae tendineae 60 in a radially inward direction, thereby creating tension in the native valve 12 to reduce regurgitation and reduce paravalvular leakage around the prosthetic heart valve 110.
  • FIGS. 17-19 show the balloon assembly 62, it is understood that the coil device 10 of FIGS.
  • a coil device comprising a support member and at least one expandable member (such as the balloon assemblies 62, 88, 94a, and 94b, or the braid assembly 102, for example) can repair or reduce regurgitation through a native valve by applying an inward radial force on the native heart valve to increase tension within native valve leaflets, native chordae tendineae, or both the native valve leaflets and the native chordae tendineae.
  • Sterilization Any of the systems, devices, apparatuses, etc.
  • any of the methods herein can include sterilization of the associated system, Attorney Docket No: THVMC-23550WO01 device, apparatus, etc. as one of the steps of the method.
  • heat/thermal sterilization include steam sterilization and autoclaving.
  • radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam.
  • chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde.
  • Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.
  • Delivery Techniques [0172] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta.
  • the prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand).
  • a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve.
  • a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or right parasternal mini- thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.
  • the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus.
  • the prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial Attorney Docket No: THVMC-23550WO01 septum), into the left atrium, and toward the native mitral valve.
  • a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.
  • the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus.
  • the prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve.
  • a similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve/pulmonary artery.
  • Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.
  • the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art. Simulation Attorney Docket No: THVMC-23550WO01 [0177] The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with body parts, heart, tissue, etc. being simulated). [0178] The treatment techniques, methods, steps, etc.
  • Example 1 In view of the above described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application. [0180] Example 1.
  • An implantable device for treating a native heart valve comprising: a support member comprising a first end, a second end, and a coiled section disposed between the first end and the second end; and a balloon comprising a balloon wall and extending radially around at least a portion of the coiled section of the support member, wherein the balloon defines an inner lumen of the implantable device and the balloon is movable from a delivery configuration to a deployed configuration, wherein the inner lumen has a first inner diameter in the delivery configuration and a second inner diameter in the deployed configuration, the second inner diameter being smaller than the first inner diameter.
  • Example 3 The implantable device of any example herein, particularly example 1, wherein the balloon comprises an inflation port extending through the balloon wall and through which a fluid can be injected to expand the balloon.
  • Example 3 The implantable device of any example herein, particularly example 2, wherein the inflation port comprises a seal.
  • Example 4 Attorney Docket No: THVMC-23550WO01
  • Example 5 The implantable device of any example herein, particularly any of examples 1-4, wherein a balloon wall material comprises silicone, a thermoplastic polyurethane, polyamide, co-polyamide, polyethylene terephthalate, polybutylene terephthalate, thermoplastic elastomer copolyester, or combinations thereof.
  • Example 6 The implantable device of any example herein, particularly any of examples 1-5, further comprising a cover disposed over at least a portion of the balloon.
  • Example 7. The implantable device of any example herein, particularly example 6, wherein the cover comprises a fabric, a coating, or combinations thereof.
  • the implantable device of any example herein, particularly any preceding example wherein the coiled section of the support member is configured to encircle native valve leaflets and native chordae tendineae of the native heart valve, and wherein the coiled section and the balloon in the deployed configuration together are configured to apply an inward radial force on the native heart valve to increase tension within the native valve leaflets, the native chordae tendineae, or both the native valve leaflets and the native chordae tendineae and reduce regurgitation through the native heart valve, wherein the inward radial force can be adjusted by varying the second inner diameter.
  • Example 9 Example 9
  • Example 10 The implantable device of any example herein, particularly any preceding example, wherein the coiled section of the support member and the balloon are configured to receive a prosthetic heart valve and to secure the prosthetic heart valve relative to the native anatomy.
  • Example 10 The implantable device of any example herein, particularly any of examples 1-9, wherein the implantable device further comprises an additional balloon extending radially around at least a portion of the coiled section of the support member and the inner lumen has a fourth inner diameter, wherein the additional balloon is movable from the delivery configuration to a deployed configuration defining the fourth inner diameter.
  • Example 11 The implantable device of any example herein, particularly example 10, wherein the additional balloon comprises a second inflation port.
  • Example 12 An implantable device for treating regurgitation in a native heart valve, the implantable device comprising: a support member comprising a first end, a second end, and a coiled section disposed between the first end and the second end; and an expandable member extending radially around at least of portion of the coiled section of the support member, wherein the expandable member defines an inner lumen of the implantable device and the expandable member is movable from a delivery configuration to a deployed configuration, wherein the inner lumen has a first inner diameter in the delivery configuration and a second inner diameter in the deployed configuration, the second inner diameter being smaller than the first inner diameter, and wherein the implantable device applies an inward radial force on the native heart valve to increase tension within native valve leaflets, native chordae tendineae, or both the native valve leaflets and the native chordae tendineae to reduce regurgitation through the native heart valve.
  • Example 13 The implantable device of any example herein, particularly example 12, wherein the expandable member is a braid.
  • Example 14 The implantable device of any example herein, particularly example 13, wherein the braid comprises a first end portion and a second end portion, wherein the first end portion is fixed to the support member and the second end portion can translate axially along the support member to expand the braid.
  • Example 15 The implantable device of any example herein, particularly example 14, wherein the second end portion is fixed to the coiled section of the support member after the braid is expanded.
  • Example 17 The implantable device of any example herein, particularly any of examples 13-15, further comprising a cover disposed over at least a portion of the braid.
  • Example 17 The implantable device of any example herein, particularly example 16, wherein the cover comprises a fabric, a coating, or combinations thereof.
  • Example 18 The implantable device of any example herein, particularly any of examples 14-17, further comprising a lead screw mechanism or a ratcheting mechanism to translate the second end portion axially along the support member during expansion.
  • Example 19 The implantable device of any example herein, particularly any of examples 12-18, wherein the coiled section of the support member and the expandable member are configured to receive a prosthetic heart valve and to secure the prosthetic heart valve relative to the native anatomy.
  • Example 20 A method of reducing regurgitation through a native heart valve, the method comprising: positioning an implantable device around native valve leaflets, native chordae tendineae, or both the native valve leaflets and the native chordae tendineae of the native heart valve, wherein the implantable device is in a delivery configuration and comprises: a support member comprising a first end, a second end, and a coiled section disposed between the first end and the second end; and an expandable member extending radially around at least a portion of the coiled section of the support member and defining an inner lumen of the implantable device, wherein the inner lumen has a first diameter in the delivery configuration; and expanding the expandable member from the delivery configuration to a deployed configuration, and wherein the inner lumen comprises a second diameter in the deployed configuration that is smaller than the first diameter such that the expandable member urges the native valve leaflets inwardly and reduces regurgitation through the native heart valve.
  • Example 21 The method of any example herein, particularly example 20, further comprising adjusting the second diameter to vary an inward radial force applied to the native heart valve to alter tension within the native valve leaflets, the native chordae tendineae, or both the native valve leaflets and the native chordae tendineae and reduce regurgitation.
  • Example 22 The method of any example herein, particularly any of examples 20 and 21, wherein the expandable member comprises an inflatable balloon.
  • Example 23 The method of any example herein, particularly example 22, further comprising attaching an inflation tube to an inflation port extending through a balloon wall to add or remove a fluid within the inflatable balloon.
  • Example 24 Example 24.
  • Example 25 The method of any example herein, particularly any of examples 23 and 24, wherein the fluid is radiopaque and the method further comprises visually monitoring the volume of the fluid within the inflatable balloon during expansion.
  • Example 26 The method of any example herein, particularly any of examples 22-25, further comprising inserting a prosthetic heart valve within an annulus of the native heart valve as part of a subsequent procedure, wherein the coiled section of the support member and the inflatable balloon encircle the native heart valve and the prosthetic heart valve.
  • Example 27 Example 27.
  • Example 28 The method of any example herein, particularly example 26, further comprising deflating the inflatable balloon before inserting the prosthetic heart valve within the annulus.
  • Example 28 The method of any example herein, particularly any of examples 26 and 27, further comprising expanding the inflatable balloon after inserting the prosthetic heart valve, Attorney Docket No: THVMC-23550WO01 wherein the second diameter is configured to cooperate with the prosthetic heart valve to secure the prosthetic heart valve in place.
  • Example 29 The method of any example herein, particularly any of examples 22-28, wherein the implantable device further comprises a second balloon.
  • Example 30 Example 30.
  • Example 31 The method of any example herein, particularly example 29, further comprising attaching a second inflation tube to a second inflation port extending through a wall of the second balloon to add or remove a fluid within the second balloon.
  • Example 31 The method of any example herein, particularly example 30, further comprising using the second inflation tube to adjust a volume of the fluid within the second balloon to vary a third diameter.
  • Example 32 The method of any example herein, particularly any of examples 20 and 21, wherein the expandable member comprises a braid.
  • Example 33 Example 33.
  • Example 34 The method of any example herein, particularly example 33, further comprising relaxing the braid before inserting the prosthetic heart valve within the annulus.
  • Example 35 The method of any example herein, particularly any of examples 33-34, further comprising expanding the braid after inserting the prosthetic heart valve, wherein the second diameter is configured to cooperate with the prosthetic heart valve to secure the prosthetic heart valve in place.
  • Example 36 A method comprising sterilizing the prosthetic heart valve, apparatus, and/or assembly of any example.
  • Example 37 A prosthetic heart valve of any one of examples 1-36, wherein the prosthetic heart valve is sterilized.
  • the features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated.
  • any one or more of the features of one implantable device can be combined with any one or more features of another implantable device.
  • any one or more features of a method of reducing regurgitation can be combined with any one or more features of another method of reducing regurgitation.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

Sont divulgués des procédés et des ensembles pour réduire la régurgitation à travers une valvule cardiaque native. Un dispositif implantable pour traiter une valvule cardiaque native comprend un élément de support ayant une section enroulée et un élément expansible s'étendant radialement autour de l'élément de support dans une partie de la section enroulée. L'élément expansible définit une lumière interne et peut passer d'une configuration de pose à une configuration déployée, la lumière interne ayant un premier diamètre dans la configuration de pose et un second diamètre plus petit dans la configuration déployée. Le second diamètre est ajusté pour ajuster une force radiale vers l'intérieur appliquée à la valvule native, augmentant la tension à l'intérieur des feuillets valvulaires natifs, des cordages tendineux natifs, ou à la fois des feuillets valvulaires natifs et des cordages tendineux natifs de la valvule native, réduisant ainsi le reflux à travers la valvule native.
PCT/US2024/058981 2024-01-25 2024-12-06 Dispositifs et procédés de réparation de valvules cardiaques Pending WO2025159844A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202463625096P 2024-01-25 2024-01-25
US63/625,096 2024-01-25

Publications (1)

Publication Number Publication Date
WO2025159844A1 true WO2025159844A1 (fr) 2025-07-31

Family

ID=94278153

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2024/058981 Pending WO2025159844A1 (fr) 2024-01-25 2024-12-06 Dispositifs et procédés de réparation de valvules cardiaques

Country Status (1)

Country Link
WO (1) WO2025159844A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6730118B2 (en) 2001-10-11 2004-05-04 Percutaneous Valve Technologies, Inc. Implantable prosthetic valve
US9393110B2 (en) 2010-10-05 2016-07-19 Edwards Lifesciences Corporation Prosthetic heart valve
US20200107932A1 (en) * 2018-10-03 2020-04-09 Edwards Lifesciences Corporation Spring and coil devices for papillary muscle approximation and ventricle remodeling
WO2020247907A1 (fr) 2019-06-07 2020-12-10 Edwards Lifesciences Corporation Systèmes, dispositifs et procédés de traitement de valvules cardiaques
CN113576716A (zh) * 2021-08-25 2021-11-02 成都菲戈医疗科技有限公司 一种心脏瓣膜假体
WO2022087336A1 (fr) 2020-10-23 2022-04-28 Edwards Lifesciences Corporation Dispositif d'accueil de valve prothétique

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6730118B2 (en) 2001-10-11 2004-05-04 Percutaneous Valve Technologies, Inc. Implantable prosthetic valve
US9393110B2 (en) 2010-10-05 2016-07-19 Edwards Lifesciences Corporation Prosthetic heart valve
US20200107932A1 (en) * 2018-10-03 2020-04-09 Edwards Lifesciences Corporation Spring and coil devices for papillary muscle approximation and ventricle remodeling
WO2020247907A1 (fr) 2019-06-07 2020-12-10 Edwards Lifesciences Corporation Systèmes, dispositifs et procédés de traitement de valvules cardiaques
US20220079749A1 (en) * 2019-06-07 2022-03-17 Edwards Lifesciences Corporation Systems, devices, and methods for treating heart valves
WO2022087336A1 (fr) 2020-10-23 2022-04-28 Edwards Lifesciences Corporation Dispositif d'accueil de valve prothétique
CN113576716A (zh) * 2021-08-25 2021-11-02 成都菲戈医疗科技有限公司 一种心脏瓣膜假体

Similar Documents

Publication Publication Date Title
US20240285396A1 (en) Prosthetic valve docking device
US20230355388A1 (en) Delivery apparatus and methods for prosthetic valve docking devices
US20240390140A1 (en) Guide catheter for an implant delivery apparatus
US20240173121A1 (en) Prosthetic valve docking device
CA3236717A1 (fr) Ballonnet de catheter ayant des segments de conformite variable
JP2023547915A (ja) 弁周囲漏出を低減するための装置および方法
US20240299164A1 (en) Prosthetic valve delivery apparatus with strain relief nosecone
WO2024258839A1 (fr) Cathéters à ballonnet pour implants prothétiques
WO2025019179A1 (fr) Pointes atraumatiques pour appareil de pose d'implant prothétique
WO2025050081A1 (fr) Élément d'étanchéité de fuite paravalvulaire pour valve prothétique
WO2025159844A1 (fr) Dispositifs et procédés de réparation de valvules cardiaques
US20250345174A1 (en) Prosthetic medical device delivery system
CN221205790U (zh) 一种被配置成递送假体植入物的递送设备
CN220370092U (zh) 对接装置和防护构件
US20250387225A1 (en) Prosthetic medical device delivery apparatus
US20250186193A1 (en) Prosthetic valve docking devices
US20250248811A1 (en) Implantable devices and sealing members and associated methods
US20250041055A1 (en) Pressure-reduction systems and methods for prosthetic valves
US20250281281A1 (en) Prosthetic valve docking device
WO2025019171A1 (fr) Dispositif d'implantation de prothèse valvulaire
JP2025504083A (ja) 人工インプラント用の送達装置
WO2024220192A1 (fr) Dispositif d'accueil de prothèse valvulaire
WO2024191576A1 (fr) Ensemble de pose de dispositif médical prothétique
WO2024186723A1 (fr) Appareil de pose de dispositif médical prothétique
WO2025101566A1 (fr) Systèmes de pose pour valvules cardiaques prothétiques

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 24837238

Country of ref document: EP

Kind code of ref document: A1